CRA II
About the role
This vacancy has now expired. Please see similar roles below...
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.
We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.
Job Title : Clinical Research Associate II
Type of Employment : Full Time
Location : ICON PLC - Bengaluru INDIA
Position Summary
- 4+ years of experience in monitoring
- hands-on experience in Oncology Trials & Therapeutic area
- Required days on-site - 8.5 to 12 Days per month.
- PAN India Travel involved.
Job Description :
- Recognize, exemplify and adhere to ICON"s values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Ability and willingness to travel at least 60% of the time.(international and domestic : fly and drive)
- Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.
- Familiarity with ICON systems .
- Maintain timelines . Ensure accuracy and completeness of data entered into ICON systems.
- Recruitment of investigators .
- Independent and proactive coordination of all the necessary activities required to set up and monitor a study ,
Including but not limited to the following :
- Identify investigators.
- Help when requested , in preparation of regulatory submissions . Design of patient information sheets and consent forms .
- Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate
- Maintain all files and documentation pertaining to studies . Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.
- Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
- Keep the Project Manager regularly informed.
- Process case record forms to the required quality standards and timelines . Deal with sponsor generated queries in a timely manner.
- Ensure the satisfactory close-out of investigator sites .
- Participate, if requested, in the preparation of and review of study documentation , e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
- Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study .
- Maintain patient and sponsor confidentiality .
- Assume additional responsibilities as directed by the Project Manager.-
lnvestigational Products (IPs) stored and managed by the site:
- Ensure storage conditions and acceptable supplies are provided
- Ensure IPs are supplied only to eligible patients
- Ensure IP receipt, use and return are controlled and documented
- Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
- Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate .
- Participate in data listing reviews, as applicable .
- Responsible for cost effectiveness
- Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
- Assist with marketing the company if and when appropriate . Other duties as assigned .
Technical and competency selection:
When you spot an opportunity you're interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business. The evaluation will look at your technical skills and your competencies - for example, delivering excellence.
Interview
After this, we'll let you know if we'll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.
Offer
If you're successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have - and above all, welcome you to the ICON team.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Shanghai
Department
Clinical Operations Roles
Location
Shanghai
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109845
Expiry date
01/01/0001
Author
Lai "Jenny" ZhangAuthor
Lai "Jenny" ZhangSalary
Location
US, Salisbury, NC
Location
Salisbury
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Research Site Services
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117424
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
Canada, Burlington
Department
Clinical Monitoring
Location
Burlington
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Requirements: 12+ months of monitoring experience as a CRA for a sponsor or CROOncology experience as a CRA Located in Ontario, Canada At ICON, it’s our people that set us apart. Our diverse teams ena
Reference
JR117798
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
The Study Start-Up Associate (SSUA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in
Reference
2024-108919
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
US, San Antonio, TX, IDS
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
San Antonio
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Laboratory
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR113018
Expiry date
01/01/0001
Author
Alexis HenryAuthor
Alexis HenrySalary
Location
Netherlands
Department
Clinical Monitoring
Location
Netherlands
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109724
Expiry date
01/01/0001
Author
Vanessa VerdicktAuthor
Vanessa Verdickt